Long-term efficacy and safety of 12 months of valganciclovir prophylaxis compared with 3 months after lung transplantation: A single-center, long-term follow-up analysis from a randomized, controlled cytomegalovirus prevention trial
Long-term efficacy and safety of 12 months of valganciclovir prophylaxis compared with 3 months after lung transplantation: A single-center, long-term follow-up analysis from a randomized, controlled cytomegalovirus prevention trial
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DOI：
10.1016/j.healun.2011.02.017
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发表时间：
2011-09-01
影响因子：
8.9
通讯作者：
Palmer, Scott M.
中科院分区：
文献类型：
--
作者：
Copeland, C. Ashley Finlen;Davis, W. Austin;Palmer, Scott M.
背景：肺移植后巨细胞病毒（CMV）预防的最佳方法存在争议。我们最近完成了一项前瞻性、随机、安慰剂对照的肺移植CMV预防研究，证明了将缬更昔洛韦预防延长至12个月与3个月治疗的短期疗效和安全性。在目前的分析中，我们监测了一个单中心亚组的患者参加了CMV预防试验，以确定是否延长预防提供了一个持续的长期效益，并评估其血液safety.METHODS：子分析包括38例随机患者从杜克大学医学中心。所有患者均接受了连续的血清CMV监测和监测支气管镜检查。CMV定义为病毒血症（>= 500 CMV DNA拷贝/ml）或肺炎。安全性评估包括对移植后所有全血细胞计数的回顾。结果：在每组平均3.9年的随访中，与短期预防相比，长期预防提供了持续的保护性获益，终生CMV发病率分别为12%和55（风险比，0.13; 95%置信区间，0.03-0.61; p = 0.009），在调整临床风险因素后，该效应持续存在。每组患者进行的外周血抽取和支气管镜检查次数相当。移植后白色血细胞，中性粒细胞和血小板计数是相似的，每个治疗组之间的随访course of follow-up.CONCLUSION：延长缬更昔洛韦预防12个月提供了一个持久的长期CMV保护的好处相比，短期治疗，不增加不良血液学影响。J Heart Lung Transplant 2011;30：990-6（C）2011年国际心肺移植学会。All rights reserved.
BACKGROUND: The optimal approach to cytomegalovirus (CMV) prevention after lung transplantation is controversial. We recently completed a prospective, randomized, placebo-controlled study of CMV prevention in lung transplantation that demonstrated the short-term efficacy and safety of extending valganciclovir prophylaxis to 12 months vs 3 months of therapy. In the current analysis, we monitored a single-center subset of patients enrolled in the CMV prevention trial to determine if extended prophylaxis conferred a sustained long-term benefit and to assess its hematologic safety.METHODS: The sub-analysis included 38 randomized patients from Duke University Medical Center. All patients underwent consistent serial serum CMV monitoring and surveillance bronchoscopies. CMV was defined by viremia (>= 500 CMV DNA copies/ml) or pneumonitis. The safety assessment included a review of all complete blood counts obtained from transplant onward.RESULTS: During a mean follow-up of 3.9 years in each group, extended-course compared with short-course prophylaxis provided a sustained protective benefit with a lifetime CMV incidence of 12% vs 55%, respectively (hazard ratio, 0.13; 95% confidence interval, 0.03-0.61; p = 0.009), an effect that persisted after adjustment for clinical risk factors. Patients in each group underwent a comparable number of peripheral blood draws and bronchoscopies. Post-transplant white blood cell, neutrophil, and platelet counts were similar between each treatment group during the course of follow-up.CONCLUSION: Extending valganciclovir prophylaxis to 12 months provides a durable long-term CMV protective benefit compared with short-course therapy, without increasing adverse hematologic effects. J Heart Lung Transplant 2011;30:990-6 (C) 2011 International Society for Heart and Lung Transplantation. All rights reserved.